Immunoglobulin Induction Therapy in Renal Transplant Recipients on Tacrolimus/Azathioprine or Tacrolimus/MMF: Effects on Th1, Th2, B Cell-/Monokine Responses and Immunoregulatory Autoantibody Levels
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patient survival
研究概览
简要总结
The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy.
Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to three years posttransplant will be analyzed.
详细描述
Intravenous immunoglobulin (IVIG) preparations are known to be effective in the treatment of various autoimmune and inflammatory disorders due to their immunomodulatory and antiinflammatory properties. It has been demonstrated that IVIG is effective in the treatment of acute vascular rejection and steroid resistant cellular rejection. Furthermore, IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized patients so that successful cadaveric or living renal transplantation could be performed.
The aim of this randomized prospective study in renal transplant recipients is to investigate immunological short and long-term effects of an IVIG induction therapy on Th1, Th2 and B-cell/monocyte responses, expression of adhesion molecules, costimulatory factors and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-F(ab)-, anti-F(ab')2G-, anti-hinge autoantibodies). These autoantibodies have been shown to significantly affect the risk of chronic rejection and graft loss.
Furthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic rejection, infectious diseases and graft function) up to 3 years will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal transplant recipients of the Giessen renal transplant unit
- •cadaveric and living renal transplants
- •first and retransplants
排除标准
- •Contraindications against blood-taking (anaemia with hemoglobin < 9,5 g/l, hypotension)
- •intravenous immunoglobulin therapy in the last half year before study entry
- •Hyperimmunoglobulin therapy for severe CMV infection
- •Pregnancy
结局指标
主要结局
patient survival
时间窗: 1 year / 3 years / 5 years posttransplant
graft survival
时间窗: 1 year / 3 years / 5 years posttransplant
acute rejection
时间窗: 1 year
chronic allograft nephropathy
时间窗: 3 years / 5 years posttransplant
次要结局
- graft function(1 year / 3 years / 5 years)
- infectious complications(1 year)
- immunoglobulin levels(1 year)
- regulatory autoantibody levels(1 year / 3 years / 5 years)
- Th1 and Th2 responses(1 year / 3 years)
- B-cell/monocyte responses(1 year / 3 years)
- Expression of adhesion molecules, costimulatory molecules and cytokine receptors(1 year / 3 years)
- proteinuria (quantitative assessment)(1 year / 3 years)